Cleared Traditional

THE COMPANION NON-ELECTRIC LIFT CHAIR (K902600) - FDA 510(k) Clearance

Class I Physical Medicine device.

K902600 · Innovative Medical Engineering, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
9d
Days
Class 1
Risk

K902600 is an FDA 510(k) clearance for the THE COMPANION NON-ELECTRIC LIFT CHAIR. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Innovative Medical Engineering, Inc. (Hawthorne, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovative Medical Engineering, Inc. devices

Submission Details

510(k) Number K902600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date June 21, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INN Chair, Adjustable, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.